Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico - Full Text View

Purpose

The purpose of this study will be to evaluate safety, tolerability and immunogenicity of 13-valent pneumococcal vaccine in healthy infants given with routine pediatric vaccinations in Mexico. The safety profile and immunogenicity of 13-valent pneumococcal vaccine will also be assessed.

Condition	Intervention	Phase
Vaccines, Pneumococcal	Biological: 13-valent pneumococcal conjugate vaccine	Phase III

Drug Information available for:

Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Phase 3, Open Label, Single Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Mexico

Further study details as provided by Wyeth:

Primary Outcome Measures:

Assessment of pneumococcal immune response after a three dose infant vaccination series. [ Time Frame: Serum pneumococcal immune response at approximately seven months of age. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of pneumococcal immune response after the second dose of the infant vaccination series. [ Time Frame: Serum pneumococcal immune response at approximately thirteen months of age. ] [ Designated as safety issue: No ]

Estimated Enrollment:	214
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Biological: 13-valent pneumococcal conjugate vaccine

Eligibility

Ages Eligible for Study:	48 Days to 98 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy 2 month infants, available for entire study period and parent/legal guardian reachable by telephone Able to complete three blood draws during study At least 3.5 kg at enrollment

Exclusion Criteria:

Previous vaccination (except Hepatitis, BCG), contraindication or allergic reaction to vaccines Immune deficiency, bleeding disorder or significant chronic medical condition

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708682

Contacts


Contact: Trial Manager		clintrialparticipation@wyeth.com

Locations


Mexico
		Not yet recruiting
	Distrio Federal, Mexico, 14080
		Not yet recruiting
	Distrio Federal, Mexico, 4530
		Not yet recruiting
	Oaxaca, Mexico, 71220
		Recruiting
	Puebla, Mexico, 72190

Mexico, Jalisco
		Not yet recruiting
	Guadalajara, Jalisco, Mexico, 44080

Mexico, Michoacan
		Not yet recruiting
	Morelia, Michoacan, Mexico, 58070

Mexico, Morelos
		Not yet recruiting
	Cuernavaca, Morelos, Mexico, 62508

Mexico, Nuevo Leon
		Not yet recruiting
	Monterrey, Nuevo Leon, Mexico, 64460

Mexico, Yucatan
		Not yet recruiting
	Merida, Yucatan, Mexico, 9700

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor	Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	6096A1-3009
First Received:	June 27, 2008
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00708682
Health Authority:	Mexico: Ethics Committee; Mexico: National Institute of Public Health, Health Secretariat; United States: Food and Drug Administration

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on November 04, 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00708682